A Medical Device Daily

The results of the DATAS (Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study) clinical trial, presented at Cardiostim 2006, the 15th World Congress in Cardiac Electrophysiology and Cardiac Techniques, in Nice, France, last week, showed that clinically significant adverse events can be reduced by one-third with dual-chamber implantable cardioverter defibrillators (DC ICDs) compared to single-chamber ICDs (SC ICDs) in patients at risk of sudden cardiac death.

The randomized, multicenter DATAS trial, supported by Medtronic (Minneapolis), analyzed 334 patients at risk of sudden cardiac death and rated their risk of adverse events. Participating centers included consecutive patients with a standard ICD indication, who were randomly assigned to DC ICDs or SC ICDs and followed for 17 months.

In both arms, the CSAE score was calculated by combining reported clinically significant adverse events including death, invasive interventions, hospitalizations, inappropriate shocks and sustained long duration of atrial tachyarrhythmias, adjusted according to their clinical severity.

In 75% to 80% of cases, sudden cardiac death is caused by ventricular fibrillation, the fast and irregular quivering of the lower chambers of the heart called ventricles. “The immediate treatment of ventricular fibrillation with a defibrillator is crucial to save people's lives,” said Jesus Almendral, MD, of the department of cardiology at Hospital General Universitario Gregorio Maranon (Madrid, Spain) and member of the steering committee of the DATAS study. “However, it is really important to use technically advanced ICDs that can adjust therapy when appropriate to reduce clinical adverse events.”

The DATAS trial showed that the rate of clinically significant adverse events was lower with DC ICDs compared to SC ICDs in patients at risk of sudden cardiac death and indicated for ICD therapy. A statistically and clinically significant 33% reduction in the rate of adverse events was documented in the DC ICD group by the clinically significant adverse events (CSAE) score. Over a follow-up of 17 months, annual mortality was 2.7% in the DC ICD group and 6.8% in patients treated with a single-chamber ICD.

Inappropriate shocks were registered in 1.3% of patients per year of follow-up with DC ICDs vs. 6.8% of those with SC ICDs. Overall, patients with DC ICDs had a lower or similar incidence of each kind of clinically significant adverse events compared to those with SC ICDs.

“By monitoring both the atrium and ventricle in the heart, DC ICDs can diagnose the nature of the arrhythmia and distinguish atrial from ventricular tachyarrhythmias, or the loss of synchrony between the two chambers,” said Almendral. “This is very important to administer the most suitable therapy to reset the heart rhythm.”

Dual-chamber ICDs have two leads that monitor the right atrium and the right ventricle, can defibrillate the ventricle, and pace both the atrium and the ventricle in atrio-ventricular synchrony. For patients with bradycardia pacing needs – either at time of implant or that which develops in the future – features like Managed Ventricular Pacing, found in certain Medtronic dual-chamber devices, reduce unnecessary right ventricular pacing by 99%, the company said.

In addition, dual-chamber ICDs provide superior SVT discrimination to further reduce inappropriate shocks as compared to SC ICDs, as well as diagnostics to better monitor atrial fibrillation or heart failure disease progression.

“The results of the DATAS trial support the superiority of sophisticated DC ICDs in distinguishing and treating atrial and ventricular tachyarrhythmias to save people's lives,” said Steve Mahle, president of the Cardiac Rhythm Disease Management business at Medtronic.

The latest and most advanced DC ICD manufactured by Medtronic, the Virtuoso, recently received FDA approval and the CE mark and is now available in both Europe and the U.S.

U.S. Phase II trial seen for Varisolve

BTG (London) said it intends to complete preparations for and commence a Phase II clinical safety study of Varisolve, a novel injectable microfoam treatment for varicose veins, in the U.S.

The company said that, while its preferred strategy had been to partner the program prior to commencing a U.S. Phase II safety study, it now intends to move forward with the study, which it is able to fund from existing resources without impacting current development activities in the broader BTG pipeline, in order to maintain development progress and to continue to build value in the product while continuing partnering discussions.

CEO Louise Makin said, “We have decided to progress this study so that we can maintain momentum and generate important safety data on Varisolve. We will in parallel continue to pursue all partnering options for Varisolve, recognizing that some potential partners may first want to see positive data emerging from the study.”

The Phase II study will explore the safety of Varisolve in 50 patients who have a patent foramen ovale (PFO), a defect whereby the small hole that connects the right and left atria of the heart to improve fetal circulation does not close at birth. Under certain conditions, PFOs allow blood (and potentially clots, particles or bubbles within the blood) to travel from the right atrium into the left atrium, then out of the heart and into the arterial system. The study aims to answer the FDA questions as to whether the microbubbles in Varisolve that cross through the PFO can cause sub-clinical effects in the brain such as microinfarcts.

BTG has successfully completed a pivotal European Phase III trial for Varisolve in which 435 patients were treated with the product and followed up for one year.

Fibrin Microbead patent claims allowed

Ortec International (New York), which is focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, said it has been notified by the European Patent Office that the claims of its patent application, “Fibrin Microbeads and uses thereof,” have been allowed.

Five U.S. patents relating to the Fibrin Microbead technology have previously been granted.

Ron Lipstein, Ortec's vice chairman and CEO, said, “The allowance of the patent claims by the European Patent Office underscores the uniqueness of the Fibrin Microbead technology and its role in stem cell therapy. The allowance of the claims, which paves the way for the potential issuance of multiple patents throughout Europe, is another milestone toward the development and commercialization of this technology.”

The Fibrin Microbead technology, developed at Hapto Biotech, Ortec's wholly owned subsidiary in Israel, is a matrix for the isolation, expansion and differentiation of matrix-dependent cells including Mesenchymal-type adult stems cells and their potential reimplantation into the patient.

New BioDefense Report Covers Agents, Vaccines, Competitors

The Biodefense Market Report 2006: Vaccines, Therapeutics and Diagnostics for Bioterror Agents has been released. Produced by BioAbility (Durham, North Carolina) and published by Medical Device Daily's sister publication, BioWorld Today, the report provides data and information on the companies, markets and products targeted against the CDC's list of potential bioterror agents.

The report provides background information on dis-eases, their causative agents, their incidence and prevalence worldwide, with the markets analyzed. The report covers 240 companies, organizations or institutions.

“With the recent increases in funding from national governments, there has been a large influx of companies seeking to enter the biodefense industry,” said managing editor Michael Harris.

To view sample pages, the table of contents and ordering information, visit www.BioWorld.com. Or call 404-262-5476 or 800-688-2421 for more information.